Trial · NCT02881008
Myrcludex B vs Entecavir in Patients With HBeAg Negative Chronic Hepatitis B
NCT02881008, Phase 1, Phase 2, Completed, Hepatera Ltd.; results first posted 2018-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Myrcludex B vs Entecavir in Patients With HBeAg Negative Chronic Hepatitis B. Trials, record NCT02881008. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02881008
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Myrcludex B vs Entecavir in Patients With HBeAg Negative Chronic Hepatitis B
- NCT number
- NCT02881008
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Hepatera Ltd.
- Conditions
- Chronic Hepatitis B
- Interventions
- Entecavir, Myrcludex B
- First posted
- 2016-08-26
- Last updated
- 2018-09-19
- Results first posted
- 2018-09-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With HBsAg Response at 12 Week of Therapy | 12 week | HBsAg response is defined as serum HBsAg decline of at least 0.5 logs IU/ml (or HBsAg negativation) at week 12 compared to baseline. |
| Secondary | Proportion of Patients With HBsAg Response at 24 Week of Therapy | 24 weeks | HBsAg response is defined as serum HBsAg decline of at least 0.5 logs IU/ml (or HBsAg negativation) at week 24 compared to baseline. |
| Secondary | Proportion of Patients With HBV DNA Response at Week 12 of Therapy | 12 weeks | HBV DNA response is defined as persistent reduction of HBV DNA by \>1 log IU/ml or negativation at week 12 compared to baseline. |
| Secondary | Proportion of Patients With Biochemical Response at 12 Weeks of Therapy | 12 weeks | Biochemical response is defined as normalization of ALT level at week 12 compared to baseline. |
| Secondary | Proportion of Patients With cccDNA Response at 24 Week of Therapy | 24 weeks | Virological cccDNA response is defined as reduction of intrahepatic cccDNA by 0.5 logs in comparison to baseline at week 24. |
| Secondary | Proportion of Patients With HBV DNA Response at Week 24 of Therapy | 24 weeks | HBV DNA response is defined as persistent reduction of HBV DNA by \>1 log IU/ml or negativation at week 24 compared to baseline. |
| Secondary | Proportion of Patients With Biochemical Response at 24 Weeks of Therapy | 24 weeks | Biochemical response is defined as normalization of ALT level at week 24 compared to baseline. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With HBsAg Response at 12 Week of Therapy | 12 week | For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With HBsAg Response at 24 Week of Therapy | 24 weeks | This variable was assessed in the patients administered 24-week treatment: patients of Arm F who received Myrcludex B 10 mg and patients of Arm D who received Entecavir 0.5 mg. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With HBV DNA Response at Week 12 of Therapy | 12 weeks | For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With Biochemical Response at 12 Weeks of Therapy | 12 weeks | Only patients with abnormal ALT levels at baseline were included in data analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With cccDNA Response at 24 Week of Therapy | 24 weeks | Virological cccDNA response was to be estimated only for patients of group F administered 24-week therapy with Myrcludex B in the dose of 10 mg and to whom liver biopsy during screening period and at week 24 was performed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With HBV DNA Response at Week 24 of Therapy | 24 weeks | This variable was assessed in the patients administered 24-week treatment: patients of Arm F who received Myrcludex B 10 mg and patients of Arm D who received Entecavir 0.5 mg. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With Biochemical Response at 24 Weeks of Therapy | 24 weeks | This variable was assessed in the patients administered 24-week treatment: patients of Arm F who received Myrcludex B 10 mg and patients of Arm D who received Entecavir 0.5 mg. Only patients with abnormal ALT levels at baseline were included in data analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With HBsAg Response at 12 Week of Therapy | Arm A | 0 | Participants | ||
| Proportion of Patients With HBsAg Response at 12 Week of Therapy | Arm B | 0 | Participants | ||
| Proportion of Patients With HBsAg Response at 12 Week of Therapy | Arm C | 1 | Participants | ||
| Proportion of Patients With HBsAg Response at 12 Week of Therapy | Arm D | 0 | Participants | ||
| Proportion of Patients With HBsAg Response at 12 Week of Therapy | Arm E | 0 | Participants | ||
| Proportion of Patients With HBsAg Response at 12 Week of Therapy | Arm F | 0 | Participants | ||
| Proportion of Patients With HBsAg Response at 24 Week of Therapy | Arm D | 0 | Participants | ||
| Proportion of Patients With HBsAg Response at 24 Week of Therapy | Arm F | 0 | Participants | ||
| Proportion of Patients With HBV DNA Response at Week 12 of Therapy | Arm A | 2 | Participants | ||
| Proportion of Patients With HBV DNA Response at Week 12 of Therapy | Arm B | 0 | Participants |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A | 8 | |
| Overall Study | STARTED | Arm B | 8 | |
| Overall Study | STARTED | Arm C | 8 | |
| Overall Study | STARTED | Arm D | 8 | |
| Overall Study | STARTED | Arm E | 8 | |
| Overall Study | STARTED | Arm F | 8 | |
| Overall Study | COMPLETED | Arm A | 8 | |
| Overall Study | COMPLETED | Arm B | 8 | |
| Overall Study | COMPLETED | Arm C | 8 | |
| Overall Study | COMPLETED | Arm D | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events258
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eosinophilia | Blood and lymphatic system disorders | Arm A | 2 | 8 | 2 |
| other | Eosinophilia | Blood and lymphatic system disorders | Arm B | 0 | 8 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Arm C | 0 | 8 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Arm D | 0 | 8 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Arm E | 0 | 8 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Arm F | 2 | 8 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm A | 0 | 8 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm B | 0 | 8 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm C | 0 | 8 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm D | 0 | 8 | 0 |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | 0 | 8 |
| Total, all-cause mortality | Arm B | 0 | 8 |
| Total, all-cause mortality | Arm C | 0 | 8 |
| Total, all-cause mortality | Arm D | 0 | 8 |
| Total, all-cause mortality | Arm E | 0 | 8 |
| Total, all-cause mortality | Arm F | 0 | 8 |
| Total, other adverse events | Arm A | 4 | 8 |
| Total, other adverse events | Arm B | 6 | 8 |
| Total, other adverse events | Arm C | 5 | 8 |
| Total, other adverse events | Arm D | 2 | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm D vs Arm F: Proportion of Patients With HBsAg Response at 24 Week of Therapy | Trial comparisons |
| Arm D vs Arm F: Proportion of Patients With Biochemical Response at 24 Weeks of Therapy | Trial comparisons |
| Arm D vs Arm F: Proportion of Patients With HBV DNA Response at Week 24 of Therapy | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02881008
GET https://conductscience.org/api/trials/v1/NCT02881008/results?page=2